Cosmaceutical Research Lab Inc. – FDA Warning Letter, Nov 22, 2019

The FDA inspected Cosmaceutical Research Lab Inc. in Surrey, BC, Canada, from November 18-22, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm performed extra, ambiguously named HPLC injections without clear purpose, and failed to retain all analytical data. Torn quality and production documents were found in the trash. The firm's response lacked detail on comprehensive remediation. 2. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** The firm lacked impurity testing for products like (b)(4) and (b)(4) (which may contain a potentially carcinogenic impurity), and used deficient analytical test methods (e.g., AM-011) that did not adequately evaluate range, accuracy, or precision. 3. **Insufficient Stability Testing Program (21 CFR 211.166(a)):** The firm lacked stability-indicating methods and forced degradation studies for finished drug products. 4. **Inadequate OOS Investigations (21 CFR 211.192):** Investigations into out-of-specification results, such as for API assay, were insufficient, failing to scientifically determine root causes or broaden assessments beyond observed examples.

Additionally, two OTC